NCT01448226

Brief Summary

Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in patients (pts) with hematologic malignancies. As culture-based methods only yield results in a minority of patients, using non-culture-based methods for detection of aspergillosis in clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL) samples with polymerase chain reaction (PCR) is promising, however, the influence of current antifungal drugs on the performance of this diagnostic tool remains controversial. The aim of the trial is to elucidate on the performance of BAL PCR under antifungal treatment.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
2 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

11 years

First QC Date

October 5, 2011

Last Update Submit

April 17, 2020

Conditions

Invasive Aspergillosis

Study Arms (2)

proven or probable aspergillosis

possible aspergillosis

Eligibility Criteria

Age5 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

immunocomprimised patients with lung infiltrates and high risk for invasive aspergillosis

You may qualify if:

  • immunocomprimised patients with high risk of invasive aspergillosis and lung infiltrates
  • informed consent

You may not qualify if:

  • Children under the age of 5 years
  • Informed consent not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Innsbruck University Hospital

Innsbruck, Austria

Location

Bielefeld evangelisches Krankenhaus

Bielefeld, Germany

Location

Bochum University Hospital

Bochum, Germany

Location

Cologne University Hospital

Cologne, Germany

Location

Düsseldorf University Hospital

Düsseldorf, Germany

Location

Erlangen University Hospital

Erlangen, Germany

Location

St.-Antonius Hospital Eschweiler

Eschweiler, Germany

Location

General Hospital Frankfurt (Oder)

Frankfurt (Oder), Germany

Location

Freiburg University Hospital

Freiburg im Breisgau, Germany

Location

Halle University Hospital

Halle, Germany

Location

Heidelberg University Hospital

Heidelberg, Germany

Location

Herne University Hospital

Herne, Germany

Location

Bone Marrow Transplantation Centre Idar-Oberstein

Idar-Oberstein, Germany

Location

Jena University Hospital

Jena, Germany

Location

Ludwigshafen General Hospital

Ludwigshafen, Germany

Location

Mannheim University Hospital

Mannheim, 68167, Germany

Location

Passau General Hospital

Passau, Germany

Location

Potsdam General Hospital Ernst-von-Bergmann

Potsdam, Germany

Location

Rostock University Hospital

Rostock, Germany

Location

Ulm University Hospital

Ulm, Germany

Location

Bone Marrow Transplantation Centre Wiesbaden

Wiesbaden, Germany

Location

Würzburg University Hospital

Würzburg, Germany

Location

Related Publications (4)

  • Skladny H, Buchheidt D, Baust C, Krieg-Schneider F, Seifarth W, Leib-Mosch C, Hehlmann R. Specific detection of Aspergillus species in blood and bronchoalveolar lavage samples of immunocompromised patients by two-step PCR. J Clin Microbiol. 1999 Dec;37(12):3865-71. doi: 10.1128/JCM.37.12.3865-3871.1999.

    PMID: 10565898BACKGROUND

  • Buchheidt D, Baust C, Skladny H, Ritter J, Suedhoff T, Baldus M, Seifarth W, Leib-Moesch C, Hehlmann R. Detection of Aspergillus species in blood and bronchoalveolar lavage samples from immunocompromised patients by means of 2-step polymerase chain reaction: clinical results. Clin Infect Dis. 2001 Aug 15;33(4):428-35. doi: 10.1086/321887. Epub 2001 Jul 6.

    PMID: 11462176BACKGROUND

  • Spiess B, Buchheidt D, Baust C, Skladny H, Seifarth W, Zeilfelder U, Leib-Mosch C, Morz H, Hehlmann R. Development of a LightCycler PCR assay for detection and quantification of Aspergillus fumigatus DNA in clinical samples from neutropenic patients. J Clin Microbiol. 2003 May;41(5):1811-8. doi: 10.1128/JCM.41.5.1811-1818.2003.

    PMID: 12734210BACKGROUND

  • Hummel M, Spiess B, Cornely OA, Dittmer M, Morz H, Buchheidt D. Aspergillus PCR testing: results from a prospective PCR study within the AmBiLoad trial. Eur J Haematol. 2010 Aug;85(2):164-9. doi: 10.1111/j.1600-0609.2010.01452.x. Epub 2010 Apr 1.

    PMID: 20374275BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Aliquots of BAL Samples including fungal DNA

Study Officials

  • Dieter Buchheidt, MD

    Mannheim University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

October 5, 2011

First Posted

October 7, 2011

Study Start

January 1, 2000

Primary Completion

January 1, 2011

Study Completion

May 1, 2011

Last Updated

April 20, 2020

Record last verified: 2020-04

Locations

AU(1)DE(21)